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Gujarat leads the way as 1,500 MSMEs moving towards full compliance with revised Schedule M
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Shardul Nautiyal, Mumbai
April 01 , 2025
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Gujarat's pharmaceutical sector is taking a significant leap forward as approximately 1,500 micro, small, and medium enterprises (MSMEs) are in the process of moving towards full compliance with the revised Schedule M guidelines.
These firms are actively conducting gap analyses and submitting their compliance reports to the Drugs Controller General of India (DCGI), informed Dr. H G Koshia, Commissioner of the Gujarat Food and Drug Control Administration (FDCA).
"The Gujarat FDCA’s training initiative aligns with the state’s strategic vision of swiftly adopting and enforcing the revised Schedule M guidelines across all pharmaceutical manufacturing units. Given the increasing global demand for stringent quality assurance, adherence to these revised guidelines is critical for sustaining international trade partnerships and maintaining market access," Dr. Koshia stated.
The prompt enforcement of Schedule M will not only enhance public health protection but will also solidify Gujarat’s standing as a globally competitive pharmaceutical hub. The Gujarat FDCA has also trained 150 regulatory and enforcement officers on the revised Schedule M guidelines. These sessions, launched on October 10, 2024, in conjunction with National cGMP Day celebrations, aim to accelerate the adoption and enforcement of these crucial regulations, ensuring that manufacturers in Gujarat and India align with both national and international standards.
Dr. Koshia underscored the vital role of the revised Schedule M guidelines in ensuring quality, safety, and efficacy in pharmaceutical manufacturing. "The rapid adoption and strict enforcement of the revised guidelines are fundamental to maintaining our industry’s compliance with the highest global benchmarks," he said.
The updated Schedule M guidelines set forth stringent standards for manufacturing facilities, equipment, and quality control protocols. These revisions are essential for improving the quality of drugs produced in India, reinforcing the country's reputation as a leading pharmaceutical supplier worldwide.
Key aspects of Schedule M compliance include the integration of state-of-the-art facilities and advanced equipment to prevent contamination and uphold high production standards, strengthened quality control mechanisms ensuring that all products meet required specifications before reaching consumers, enhanced cleanliness measures in manufacturing areas to prevent cross-contamination, robust air, water, and waste management systems aligning with global environmental standards.
As Gujarat contributes over 30% of India’s pharmaceutical output, swift industry adoption of these guidelines, coupled with rigorous enforcement by the FDCA, will protect consumers while strengthening the state’s position in the global pharmaceutical supply chain.
"The training programs also emphasize the role of innovation in sustaining Schedule M compliance, encouraging the adoption of new technologies in manufacturing and quality control to enhance efficiency and minimize non-compliance risks. With Gujarat leading the charge in pharmaceutical regulation and compliance, the state is setting a benchmark for the rest of the country, ensuring that India continues to uphold its reputation as a trusted global pharmaceutical powerhouse," Dr. Koshia explained.
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